ES2743898T3 - Nicotine Powder Inhaler - Google Patents

Abstract

A nicotine powder inhaler (10) comprising: a body extending between a mouthpiece portion (12) and a distal end portion (14); an air flow channel (13, 15) extending between the nozzle portion (12) and a distal end portion (14); a nicotine powder receptacle (30) disposed along the air flow channel (13, 15); a capsule (20) received in the nicotine powder receptacle (30), the capsule comprising a dose of nicotine powder, wherein the nicotine powder comprises nicotine salt; wherein the dose of nicotine powder can be inhaled into the lungs of a user at an inhalation rate of less than about 5 L / min.

Description

DESCRIPTION

Nicotine Powder Inhaler

This description refers to nicotine powder inhalers, where nicotine powder is supplied at low air flow rates.

Dry powder inhalers (DPI) are known and used to treat respiratory diseases by supplying a dry powder comprising a pharmaceutical product, in aerosol form through inhalation into the patient's airways. For a deep supply into the lungs, particles in the range of 1 to 5 micrometers are required. In pharmaceutical products in the form of dry powder, the active pharmaceutical ingredient (API) is agglomerated on the surface of larger carrier particles, for example lactose, and the DPI therefore operate complex mechanisms to ensure that such agglomerates are dispersed, divided or disaggregate before the API can be inhaled deeply into the lungs. Pharmaceuticals in the form of dry powder containing lactose as a carrier are typically in the range of 20 to 100 micrometers. Existing IPRs, for example, first "grind" or deagglomerate dry powder or impact larger particles of dry powder to result in the above-mentioned particle size range.

DPIs depend on the strength of the patient's inhalation to drag the dust from the device, to subsequently divide the powder into particles that are small enough to enter the lungs. Inhalation rates high enough to establish the correct dose and complete disintegration of the powder are required. Typically a large amount of API remains attached to the surface of the carrier and is deposited in the upper airways due to a complete disaggregation of the powder. Inhalation rates of existing DPIs are usually in the range of 40-120 liters / min (l / min). Existing IPRs are therefore only suitable for delivering dry powders to users in a manner that is different from the inhalation rate associated with smoking articles.

EP 2 399 637 A1 describes a smokeless cigarette 1 comprising a hollow cylindrical suction support 2 open at each end. A hollow cylindrical tobacco cartridge 20 is disposed within the support 2 in a distal portion of the support 2. The tobacco cartridge 20 comprises a cylindrical container 6 open at each end, and a load 8 arranged in the container 6. Permeable lids are placed in air 10 at any end of the container 6. A filter 12 is installed in the container 6, near the end of the side container 6 of the end of the mouth side 4. The filter 8 and the filter 12 are separated from each other by a stop filter filter 14. In this way, the tobacco cartridge 20 is placed inside the holder 2 with the end of the side container 6 of the filter 12 towards the end of the side of the mouth 4. A lid 16 is removably mounted at the end open distally of the support 2 away from the end of the side of the mouth 4. The cover 16 has an air inlet 18. The support 2 has an air suction path so that the air introduced through the air inlet 18 flows. The suction path includes a main passage that extends from the air inlet 18 to the end of the side of the mouth 4, inside the support 2. The filter 8 is formed by containing a mixture of pieces of tobacco or grains, obtained by grinding or granulating tobacco leaves, and additives, in the container 6 so that the tobacco cartridge 20 provides a predetermined ventilation resistance. By the action of suction of the user at the end of the side of the mouth 4 of the support 2, air is introduced into the tobacco cartridge 20 through the air inlet 18, and contacts the filling 8, or tobacco particles. Therefore, within the cartridge 20, the air receives a tobacco flavor by containing flavoring substances released by the tobacco particles. In this way, the user can inhale the tobacco-flavored air, through the main passage and the end of the mouth side 4 of the support 2, and enjoy the taste of tobacco.

It would be convenient to provide a nicotine powder inhaler that can deliver nicotine powder to a user at airflow or inhalation rates that are close to or within the airflow or inhalation rates of the conventional smoking regime. It would be convenient to provide a nicotine powder inhaler that is similar in size and configuration to a conventional cigarette. It would be convenient to provide a nicotine powder inhaler that can provide a measured dose of nicotine and an optimal simultaneous supply of a second active ingredient.

The nicotine powder inhalers of the invention described herein can be used to deliver nicotine to a user at air flow or inhalation rates that are within the air flow or inhalation rates of the conventional smoking regime. Nicotine powder inhalers can provide a measured and predictable dose of nicotine or other optimal active ingredients. The nicotine powder inhalers of the invention described herein have a configuration and size similar to a conventional cigarette and have a simple configuration.

As described herein, a nicotine powder inhaler according to the invention includes the features of claim 1. This includes a body that extends between a mouthpiece and a distal end portion and an air flow channel. It extends along the body of the inhaler. A nicotine powder receptacle disposed along the air flow channel receives a capsule comprising a dose of nicotine powder, wherein the nicotine powder comprises a nicotine salt. The dose of nicotine powder can be inhaled into a user's lungs at an inhalation rate of less than about 5 l / min or preferably less than about 2 l / min. The dose of nicotine powder is contained in a capsule that can be punctured by the inhaler.

Several aspects of the nicotine powder inhalers described herein may have one or more advantages over standard dry powder inhalers. For example, nicotine powder inhalers supply dry powdered nicotine at airflow or inhalation rates that are within the airflow or inhalation rates of the conventional smoking regime or by way of inhalation. This allows users even with diminished or compromised breathing conditions to successfully supply dry powdered nicotine and the second optimal active ingredients. The nicotine powder inhalers described herein have a simplified configuration that allows the user to predetermine the dose of dry powdered nicotine and the second optimal active ingredients measured. The dried powdered nicotine used with this inhaler, and those described herein, is free of a carrier and has a constant size from storage to inhalation. The additional advantages of one or more aspects of the flavoring delivery system described in the present description will be apparent to those skilled in the art after reading and understanding the present description.

The term "nicotine" refers to nicotine and nicotine derivatives such as nicotine salts.

The present description provides nicotine powder inhalers to inhale dry nicotine powder. Nicotine powder inhalers include a body that extends between a mouthpiece portion and a distal end portion. An air flow channel that extends between the nozzle portion and a distal end portion; The nicotine powder receptacle is disposed along the air flow channel and receives a capsule comprising a dose of nicotine powder, wherein the nicotine powder comprises a nicotine salt. Surprisingly, the dose of nicotine powder can be inhaled into a user's lungs at an inhalation rate of less than about 5 l / min or less than about 2 l / min that mimics the inhalation flow rate used for a conventional smoking regime. The nicotine powder inhalers described here are "passive" devices that use only the flow of inhalation air created by a user's lungs to create an air flow through the body of the nicotine powder inhaler.

The air flow path or air flow channel through the inhaler body is a simple channel or path. In many embodiments, the air flow path or air flow channel through the inhaler body is parallel to a longitudinal axis of the inhaler and extends linearly along the entire length of the inhaler body. In some embodiments, the inhaler includes two or three coextensive airflow channels. One, two or all three air flow channels may include a capsule type receptacle. In some embodiments the one or more airflow paths or airflow channels include a swirling element that is configured to induce a rotational movement of the airflow that moves through the body of the inhaler. The eddy generating elements can discharge into an outlet channel that can be a volume greater than the one or more individual air flow paths or air flow channels.

The nicotine powder receptacle receives a nicotine powder capsule. The capsule comprises a predetermined amount or dose of nicotine powder. In many embodiments the capsule may contain enough nicotine powder to provide at least 2 inhalations or "puffs" of nicotine powder, or at least about 5 inhalations or "puffs" of nicotine powder, or at least about 10 inhalations or "puffs" "Of nicotine powder. In many embodiments, the capsule may contain enough nicotine powder to provide about 5 to 50 inhalations or "puffs" of nicotine powder, or about 10 to 30 inhalations or "puffs" of nicotine powder. Each inhalation or "puff" of nicotine powder may deliver from about 0.5 mg to about 3 mg of nicotine powder to the user's lungs or from about 1 mg to about 2 mg of nicotine powder to the user's lungs or approximately 1 mg of nicotine powder to the user's lungs.

In many embodiments, the capsule houses or contains at least about 5 mg of nicotine powder or at least about 10 mg of nicotine powder. In many embodiments, the capsule houses or contains less than about 30 mg of nicotine powder or less than about 25 mg of nicotine powder, or less than 20 mg of nicotine powder. In many embodiments, the capsule houses or contains about 5 mg to about 30 mg of nicotine powder or about 10 mg to about 20 mg of nicotine powder.

The capsule can be formed of an airtight material that can be pierced or pierced by inhaler. The capsule can be formed of a metallic or polymeric material that serves to keep contaminants out of the capsule but can be punctured or drilled by the inhaler during use.

The inhaler may include a piercing element or pair of opposing piercing elements that are configured to pierce the nicotine powder capsule. The piercing element or pair of opposite piercing elements continuously connects the air flow channel with the dose of nicotine powder. The piercing element or pair of opposing piercing elements can be coupled with the nicotine powder capsule after loading the nicotine powder capsule into the nicotine powder receptacle or after an actuator demands it on the body of the inhaler.

In many embodiments, nicotine powder is a pharmaceutically acceptable nicotine salt or nicotine salt hydrate. Nicotine salts or nicotine salt hydrates include nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopyruvate, nicotine glutamate or nicotine hydrochloride, for example. The compound that is combined with nicotine to form the salt or salt hydrate can be chosen based on its pharmacological effect. For example: nicotine salicylate can be given to relieve fever, such as an anti-inflammatory or analgesic; Nicotine fumarate can be administered to treat multiple sclerosis; and nicotine monopyruvate can be administered to treat chronic pulmonary obstruction disease (COPD) or to lose weight.

Nicotine powder may have any size distribution useful for inhalation delivery into a user's lungs. In many embodiments at least about 90% by weight of the nicotine powder has a particle size of about 10 micrometers or less, preferably about 7 micrometers or less. The nicotine powder preferably has an average size range of average diameter of about 0.1 to about 10 micrometers, more preferably about 1 to about 7 micrometers, even more preferably about 2 to about 6 micrometers.

Conventional dry powder inhalation formulations typically contain carrier particles that serve to increase the fluidization of the active particles since the active particles are typically too small to be influenced by the flow of air through the inhaler. The carrier particles were therefore used to improve dose uniformity by acting as a diluent or filler in a formulation. However, the nicotine powder described herein is free of a carrier. Being free of a carrier allows nicotine powder to be inhaled and delivered to a user's lungs at airflow or inhalation rates that are similar to the airflow or inhalation rates typical of the smoking regime. In addition, since the nicotine powder is free of a carrier, the airflow path of the inhaler may have a simple geometry or a simple configuration.

The carrier-free nicotine powder described herein may be a modified surface nicotine salt where the nicotine salt particle is a coated particle. A preferred coating material is L-leucine. These carrier-free nicotine powders are described and available from Teicos Pharma Inc., Espoo, Finland. A particularly useful nicotine powder is a nicotine bitartrate coated with L-leucine.

A second ingredient or active agent can be supplied together with the nicotine powder. The second active ingredient or agent may be mixed with the nicotine in the capsule or be separated from the nicotine in its own capsule. The second active ingredient or agent can be fluidized with the nicotine powder and inhaled by a user.

This second active ingredient or agent can be any active pharmaceutical material. In many embodiments, the second active ingredient or agent can be combined with the nicotine powder described herein by combining the two materials during inhalation. The nicotine powder and the second active ingredient or agent can be combined in the same capsule or provided in series in a single air flow channel in the DPI or provided in parallel in separate flow channels from the DPI. The second active ingredient or agent may have an average range of average diameter size similar to the nicotine powder described above.

The nicotine powder inhaler is less complex and has a simplified airflow and dust storage path compared to existing DPIs, and does not need a carrier ingredient, such as lactose, as described above. Therefore the complex mechanisms to dissociate / disaggregate a dry powder pharmaceutical product are not required in the described nicotine inhaler and therefore the described nicotine inhaler operates under a low air flow. The inhaler does not require the typical high inhalation rates of conventional IPRs for a deep supply of dry nicotine powder as described previously into the lungs.

The nicotine inhaler according to this invention operates using a flow rate of less than about 5 l / min or less than about 3 l / min or less than about 2 l / min or about 1.6 l / min. In many embodiments the flow rate is in a range of about 1 l / min to about 3 l / min or from about 1.5 l / min to about 2.5 l / min. In preferred embodiments the inhalation rate or flow rate is similar to that of the Health Canada smoking regimen, which is approximately 1.6 l / min. In contrast, a conventional DPI operates at a flow rate of approximately 40-120 l / min and often requires a source of energy or propellant to promote air flow to achieve this air flow rate.

The nicotine inhaler described herein can be used by a consumer as if he were smoking a conventional cigarette or steaming an electronic cigarette. Such smoking or vaporeado is characterized by two stages: a first stage during which a small volume containing the total amount of nicotine desired by the consumer is dragged into the oral cavity, followed by a second stage during which this small volume which comprises the aerosol comprising the desired amount of nicotine is further diluted by fresh air and creeps deeper into the lungs. Both stages are controlled by the consumer. During the first stage of inhalation the consumer can determine the amount of nicotine that is inhaled. During the second stage, the consumer can determine the volume to dilute the first volume that creeps deeper into inside the lungs, maximizing the concentration of the active agent supplied to the epithelial surface of the airways. This smoking mechanism is sometimes called "puff-inhale-exhale."

All scientific and technical terms used in the present description have meanings that are commonly used in the art unless otherwise specified. The definitions provided in this description are to facilitate the understanding of certain terms frequently used in this description.

The terms "upstream" and "downstream" refer to the relative positions of the inhaler elements described in relation to the direction of inhalation air flow when it is drawn through the body of the inhaler from a distal end portion toward the nozzle portion.

As used in the present description, the singular modes "a," "one," and "the" encompass modalities that have plural referents, unless the content clearly dictates otherwise.

As used herein, "o" is generally used in the sense that it includes "and / or" unless the content clearly indicates otherwise. The term "and / or" implies one or all of the items listed or a combination of any of two or more items listed.

As used herein, "has", "has", "includes", "includes", "comprises", "comprising" or the like are used in their broad sense, and generally imply "including, but it is not limited to ”. It will be understood that the expression "consisting essentially of", "consists of" and the like are included in "comprising" and the like.

The words "preferred" and "preferably" refer to embodiments of the invention that can achieve certain benefits, under certain circumstances. However, other modalities may also be preferred, under the same or other circumstances. In addition, the enumeration of one or more preferred modalities does not imply that other modalities are not useful, and it is not intended to exclude other modalities from the scope of the description, which includes the claims.

Figs. 1-7 are schematic diagrams of illustrative nicotine powder inhalers 10. Figs. 3-7 are shown with transparent bodies to more easily illustrate the flow channels and internal elements. The drawings are not necessarily to scale and are presented for purposes of illustration and not limitation. The drawings represent one or more aspects described in this description. However, it will be understood that other aspects not shown in the drawing fall within the scope of the appended claims.

Referring now to Figure 1 and Figure 2, nicotine powder inhalers 10 include a mouthpiece portion 12 and a distal end portion 14 and a nicotine capsule 20 disposed therebetween. The piercing elements 11A and 11B are configured to pierce the capsule 20 and continuously connect the air flow channel 13 of the nozzle portion 12 with the air flow channel 15 of the distal end portion 14. The The air flow extends linearly along a length of the nicotine powder inhaler 10. Figure 2 further illustrates the capsule 20 inside a receptacle 25 that can be used again.

Figure 3 and Figure 4 illustrate nicotine powder inhalers 10 having a single linear air flow channel 13, 15. The piercing elements 11A and 11B extend into a nicotine powder receptacle 30 and are configured to pierce the nicotine powder capsule and continuously connect the air flow channel 13 of the nozzle portion 12 with the air flow channel 15 of the distal end portion 14. The air flow channel extends from linearly along a length of the nicotine powder inhaler 10 from a proximal end of the mouthpiece 18 towards a distal end 19. The mouthpiece portion 12 can be connected to the distal end portion 14 by a bayonet type connection. In Figure 3 the nozzle portion 12 is not symmetrical with the distal end portion 14. In Figure 4 the nozzle portion 12 is symmetrical with the distal end portion 14.

Figure 5 and Figure 6 is an additional illustrative nicotine powder inhaler 10. Figure 6 is a view of Figure 5 taken along lines 6-6. This mode includes three air flow channels 15 and first, second and third dust receptacles 30, 32 and 33 respectively. A nicotine powder capsule can be received in at least one of the dust receptacles 30, 32 and 33. In some embodiments, a second active agent can be received in at least one of the dust receptacles 30, 32 and 33. All three Flow channels 15 are continuously connected to an output channel 40 by a swirl generator 50 configured to induce rotational movement in the air flow. The air flow channels 15 extend linearly along a length of the nicotine powder inhaler 10 from a proximal end of the mouthpiece 18 towards a distal end 19. A ventilation element 70 can be arranged along the channels air flow 15 to provide dilution air as desired.

Figure 7 is an additional illustrative nicotine powder inhaler 10. This embodiment includes three air flow channels 15A, 15B and 15C and first, second and third dust receptacles 30, 32 and 33 respectively. A nicotine powder capsule can be received in at least one of the dust receptacles 30, 32 and 33. In some embodiments, a second active agent can be received in at least one of the dust receptacles 30, 32 and 33. All three Flow channels 15 are continuously connected to an output channel 40 by a swirl generator 50 configured to induce rotational movement in the air flow. The air flow channels 15A, 15B extend linearly along a length of the nicotine powder inhaler 10 from a proximal end of the mouthpiece 18 towards a distal end 19. In some embodiments a loop element of the air flow 60 is disposed along the 15C air flow channels.

Claims (14)

1. A nicotine powder inhaler (10) comprising: a body extending between a nozzle portion (12) and a distal end portion (14); an air flow channel (13, 15) extending between the nozzle portion (12) and a distal end portion (14); a nicotine powder receptacle (30) disposed along the air flow channel (13, 15); a capsule (20) received in the nicotine powder receptacle (30), the capsule comprising a dose of nicotine powder, wherein the nicotine powder comprises nicotine salt; wherein the dose of nicotine powder can be inhaled into a user's lungs at an inhalation rate of less than about 5 l / min. 2. A nicotine powder inhaler (10) according to claim 1, further comprising opposing piercing elements (11A, 11B) configured to pierce the received capsule (20) and continuously connect the nicotine powder with the channel air flow (13, 15). 3. A nicotine powder inhaler (10) according to any of the preceding claims, wherein the air flow channel (13, 15) extends linearly along the body from the distal end portion ( 14) towards the nozzle portion (12). 4. A nicotine powder inhaler (10) according to any of the preceding claims, wherein the nicotine powder is nicotine bitartrate, nicotine salicylate, nicotine fumarate, nicotine monopiruvate, or nicotine hydrochloride. 5. A nicotine powder inhaler (10) according to any of the preceding claims, wherein at least about 90% by weight of the nicotine powder has a particle size of about 10 micrometers or less. A nicotine powder inhaler (10) according to any one of the preceding claims, further comprising a swirl generating element (50) configured to induce rotational movement in the air flow from the air flow channel ( fifteen). 7. A nicotine powder inhaler (10) according to any of the preceding claims, further comprising a second air flow channel (15, 15B) extending between the nozzle portion and a distal end portion and a second dust receptacle (32) and arranged along the second air flow channel (15, 15B). 8. A nicotine powder inhaler (10) according to any of the preceding claims, further comprising a third air flow channel (15, 15C) extending between the nozzle portion and a distal end portion and a third dust receptacle (33) disposed along the third air flow channel (15C). 9. A nicotine powder inhaler (10) according to any of the preceding claims, further comprising doses of a second active agent. 10. A nicotine powder inhaler (10) according to any claim from 7 to 9, further comprising an outlet channel (40) in fluid connection and combining the air flow of the air flow channel (15A), the second air flow channel (15B) and the third air flow channel (15C). 11. A nicotine powder inhaler (10) according to claim 10, further comprising a swirl generating element (50) configured to induce rotational movement in the air flow from the air flow channel (15A) , the second air flow channel (15B) and the third air flow channel (15C). 12. A nicotine powder inhaler according to claim 11, wherein the eddy generator (50) is in fluid connection between the air flow channel (15), the second air flow channel (15B) and the third air flow channel (15C) and the outlet channel (40) and the outlet channel (40) mix the air flow of the air flow channel (15), the second air flow channel ( 15B) and the third air flow channel (15C). 13. A method of inhaling nicotine into a user's lungs: inhaling air through the nicotine powder inhaler (10) according to any one of claims 1 to 12 at a flow rate of less than about 2 l / min to deliver the nicotine powder into the lungs of a user. 14. A method according to claim 13 further comprises inhaling a second active agent with nicotine powder through the nicotine powder inhaler (10) in accordance with any of the claims 1 to 12 at a flow rate of less than about 2 l / min to deliver the nicotine powder and the second active agent into the lungs of a user.